BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·May 13, 2020

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 1, 2015

    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 6, 2013

    Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

    FDA Enforcement
    Class II ·Terminated·Elekta Inc·December 20, 2017

    COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological

    FDA Enforcement
    Class II ·Terminated·Iba Dosimetry Gmbh·March 4, 2015

    Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·April 4, 2018

    TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 13, 2021

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·July 2, 2014

    TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 13, 2021

    Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 13, 2016

    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·August 15, 2012

    VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 27, 2013

    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·November 6, 2013

    Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA

    FDA Enforcement
    Class II ·Terminated·Covidien Llc·August 18, 2021

    First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science (Amazon)

    FDA Enforcement
    Class II ·Terminated·ASO LLC·May 11, 2022

    Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020

    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·February 26, 2020